My Comments Regarding The New NDC Format

Happy New Year!

A few hours before the end of the comment period, I submitted my comments to FDA’s docket on Regulations.gov for the new NDC format. By the time your read this, the docket will be closed. The agency that operates that web site often takes a few days to post submissions, but because of the government shutdown, I doubt if anyone will be working on it until after the government re-opens (assuming the furloughed workers haven’t gotten a better job by then…In that case, it could be even longer).

Since it could take a long time before you can see the submitted responses through Regulations.gov, here is my submission.

Basically, I only have three things to say to the FDA regarding the new format of the National Drug Code (NDC), and only the first of those is critically important. That is, it is critically important that the new format of the NDC result in a single identifier for each drug package. That’s it. Nothing else is critically important (see also “An Open Letter To The FDA: New NDC Format Public Meeting” and “FDA New NDC Format Public Meeting“). I provided one of probably several ways to accomplish this so they could see that it is possible, but there are probably multiple other ways to do it. I also provided some of my thoughts on the timing of the change.

Once all of the submissions become available I will provide an overview of those that contain significant ideas–good or bad, in my view. Watch for that!

Dirk.

6 thoughts on “My Comments Regarding The New NDC Format”

  1. Very well said, Dirk. Heaven help us all of there are still people — in ANY segment of the Healthcare supply chain — arguing about the need/cost for 2D scanners NOW, never mind in 10 years. The U. S. healthcare supplying chain is already 10-20 years behind the most advanced retail and other supply chains. And it is simplistic to say it is because healthcare is “so complex”. Most of us know better. But I digress.

    Your call for a single unique identifier as THE paramount consideration is right on the mark. And while you point out, very diplomatically, that there is more than one way to implement a single identifier, the GS1 GTIN-based solution you point out is both the easiest to implement and BEST. I hope one of you future essays will help illuminate why this is true.

  2. Hi Dirk. Thank you for sharing. And for taking the time to send the FDA such a detailed assessment. Could not agree more with your assessment as well as the previous comment re: the best approach!

    1. Jaime,
      Thanks. I would have pressed for the GS1 approach more firmly but I feared that would cause a de-emphasis of the importance of the single identifier. In my view, that’s by far the most important characteristic that results from the merging of the NDC with the GTIN. If there are other ways to do it that are not GTIN, but still result in a single identifier on all drugs, that’s better (safer) than what we have today. But the GTIN becoming the NDC is so logical and “easy” that it is the only approach that the industry should accept. I know others are going to make that point.
      Dirk.

  3. Dirk, George & Jaime, I couldn’t agree more with your comments. My past interactions with the FDA (RFID vs. 2D) makes me think that we will all have to push them to the Best answer to the perceived need. Keep talking.
    Bruce

    1. Thanks Bruce. You know well what it takes to help the FDA understand the issues and differentiate what is best from what is “best for me“. That’s why I hope to monitor the other submissions and post my own impressions of any ideas that I think have merit, as well as those I think are problematic. I hope you and others do the same. This one is too important to sit by passively while they pick the one approach that can be done without needing to buy 2D barcode readers. We all need to aim higher than that or we will spend the next 30 years with two different barcodes and 3 different identifiers on every drug package.
      Dirk.

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